Reported Apr 8, 2015 · Terminated
Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 12050 Lone Peak Pkwy · Draper, UT · 84020-9414
Is this the product you have?
- Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model
- NumbersFEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 FEMII008A/59751073, 59775775, 59775776, 59775777 & 59852930 2 FEMII008AT/59807985, 59867050, & 59873263 3 FEMII008V/59873250 & 59873251 4 FEMII010A/59740468, 59773806, 59792415, 59792416 & 59852934 5 FEMII010AT/ 59747819, 59807986,59852935, 59890916 & 59896910 6 FEMII010V/59751074, 59849119 & 59890924 7 FEMII012A/ 59801792,59867064, 59884766 & 59884778 FEMII012AT/59852940 & 59867051 8 and FEMII012V/59723307, 59796683, 59849124 & 59873252 - Amount recalled
- 5125 units
Where it was sold
- Nationwide
Why it was recalled
Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula.
This product could cause temporary or reversible health problems — stop using it.
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